00:00
Luisa Venier
Just to give you a few numbers, in 2025 we processed more than 310 access to documents requests, and we disclosed thousands of documents. So, it’s quite a resource impacting activity.
00:24
Edward Bray
Hello and welcome to another episode of Science on the Menu. My name is Ed Bray, and today we’re going to be discussing something a little bit different on your menus. Something that you probably don’t think about immediately when it comes to the food chain, and that’s the law. We’re going to be talking about access to documents, we’re going to be talking about rules on the independence of scientists, and we’re going to be talking about artificial intelligence and how that poses challenges to the legal framework that we have in Europe.
And here with me to discuss this is our own legal expert, and that’s Luisa Venier. Thank you very much for joining us, Luisa.
00:59
Luisa
Thanks to you, Edward.
01:03
Ed
Let’s start with the big question that I would have. You’re the first guest that we have who is not a scientist at EFSA, you are a legal expert. What is a legal expert doing at a food safety body like EFSA? What’s the law have to do with food safety in general?
01:24
Luisa
Actually, if you think, all EFSA operations are governed by laws, legal frameworks, regulatory framework. So, I think legal officers are very useful in the sense that as a legal unit we provide independent legal advice and support to all EFSA, with a view of allowing that the decision making is legally sound.
If you think about not only the founding regulations or our general food law 178, Regulation 178 of 2002, the transparency regulation with the new obligations that put forward the financial regulation when EFSA wants to outsource, the sectoral legislation, which is food and feed, in the food and feed areas, the personal data protection… So, everything is governed by law.
So, in addition to that, so maybe we don’t spend all the time battling in court as different lawyers, but we are legal officers that do represent EFSA before the European Union courts, or the European Union Court of Justice. So, we have that dimension as well in our daily work. In addition to that, we take administrative decisions exactly in the fields that you were mentioning before, like access to documents, like confidentiality decisions in the proactive transparency.
So yes, we don’t battle in court, but there is a lot of excitement in our daily work.
02:49
Ed
Okay. You mentioned access to documents. That sounds quite a simple thing. You have access to documents. Why would you not have that? What is access to documents? Why is that a legal question?
03:03
Luisa
Actually, it’s more than a legal question, it’s a fundamental right.
But let me one second set the scene. What is access to documents? It’s putting into action transparency. And transparency is not only providing documents that are requested by applicants, but it is also publishing. So is what we call… fundamentally we divide the transparency in two legs, has two legs, two components. One component is the proactive transparency. So, EFSA’s obligation by law, by the transparency regulation, by the founding regulation to publish all information, studies, data, supporting background of EFSA scientific outputs. And then we have the component that we call reactive, and the component that is reactive is access to documents. So you have the rights of all natural legal persons residing in one of the Member States asking access to a document that is in EFSA’s possession and our obligation to give a reply, which is yes, you get the document or you get partial access to that document, because there are certain interests to be preserved or to refuse in total the document accessibility.
04:22
Ed
Okay. You talked about certain interests to be preserved. Can you be a bit more specific there? What kind of interests are we talking about that could be at stake to be preserved?
04:30
Luisa
Yeah. So, access to documents, as I said, is a fundamental right that allows the citizens to request access to the documents. At the same time, there are certain interests of private or public nature.
And I give you a few examples. Personal data, commercial interest. So far, the disclosure will be affecting, the document disclosure will be affecting the business operators’ interest, the serenity of court proceedings. There is an exception. The documents’ disclosure should not affect the court proceedings ongoing. The purpose of investigation and the audits. So, there are bylaws and exceptions that are to be preserved, that are to be ensured and therefore the document can or can’t go out, but this requires an assessment whether certain parts of the document or the document in its entirety shall be covered by one of these exceptions. It’s all a balance of interest at the end, but let’s say that the Regulation 1049 that regulates the accessibility of the documents or the public access to documents, created the close interaction with the citizens in order to make EU institutions more accountable and more credible.
So, the rule is the accessibility of the documents. The exception are the exceptions, protections, but they are there by law. So, we need in this balancing to preserve them.
06:00
Ed
Let’s make it practical. So, imagine that I’m a citizen and I want to have access to some data from a scientific study. How would I go about requesting that information? And would I get it?
06:13
Luisa
First of all, my plea will be to ask that the citizen looks at what is already publicly available because EFSA publishes proactively a considerable amount of information, especially of scientific background nature underpinning the risk assessment. If this information you cannot find it in the EFSA website and OpenEFSA, then you can submit any time and by any means – we encourage emails or we encourage the web form that is now on the website. They can request access to the document. There is no need to particularly motivate the request. You simply submit your request identifying the document and then the law foresees a stringent procedure EFSA has, and this is centralized in the legal units, together with a scientific unit that normally are impacted by the requests.
So, the request continues by, we assess the documents, we identify the documents, we assess them. So, we assess, how? We assess the jurisprudence of the European courts, that in the last 20 years they have provided a set of case law on the applicability of these exceptions. We check the sectoral legislation, we check, we assess the interests that are at stake, and then we take a decision whether the document is accessible or not within a stringent deadline, that is 15 working days that I assure you it’s not much. Why? Because we assess all documents that are in EFSA’s possession where they are requested. But quite often these documents, they originate from third parties. So, let’s assume that this document originates from a business operator. In that case, we have the obligation to engage. We shall consult and therefore we need to wait and assess the reply of the document owner.
So, again, it’s a balancing of interests. And then we need to take a decision. The final decision lies with EFSA, within EU institution, so not with the document owner, but the document owner is put in a position to put forward the claims for confidentiality.
08:17
Ed
Okay. And in the end, it could be the court that actually decides if you’re taken to that level, that they will then decide whether or not they agree with the balance that you have struck.
08:30
Luisa
Absolutely. And we can be taken to the court by both. So, if the document owner is not satisfied about our decision to release this document, for instance, if the documents originate from them, in that case, we notify our decision. Yes, we want to give out your document under the access to documents and they say no, they can a request the annulment of our decision.
At the same time, on the opposite, if we want to protect and the applicant is unsatisfied with our decision to protect entirely or in parts of the documents requested, they can challenge us in court as well. So again, you see, the European courts are very present.
09:12
Ed
If we look at that and we look at, say, a company’s perspective and how you might interact with them, what kind of requests they might make in terms of protecting information, how do they go about that? What does that look like?
09:26
Luisa
This will be the result of the engagement we have with them. And this engagement is both in the proactive. So, what I said before, you submit a dossier to EFSA for EFSA’s risk assessment, and you shall put forward your confidentiality claims. And also there, the law foresees the procedure you put forward, the confidentiality claims. We take a decision on them. If you are not satisfied, you put forward an appeal, internal review. We take a final decision on internal review and if you’re not satisfied, there is a possibility to challenge that. If a document of a company is requested by an access to document requester, we shall consult with the document owner, as I said before, and this shall consult with a view of assessing if exceptions apply and we dialog. But then we take a final decision. And the final decision is not… is framed in the law, is framed in the jurisprudence. So, we do our best and we interact with the document owner. So, this is a bit of flow. This is a bit of procedure. And there is mechanism for appealing and then a mechanism for challenging. And the final decision is with EFSA.
10:42
Ed
Do you do you have any particular, interesting case studies or examples of cases where, you know, this has all been at stake?
10:51
Luisa
Actually, I would have many. I will say, just to give you a few numbers, in 2025, we processed more than 310 access to documents requests, and we disclosed thousands of documents. So, it’s quite a resource impacting activity. If I think about this, interesting case, possibly this is a bit technical, but you possibly have heard about the Aarhus regulation. It’s a regulation on the accessibility of environmental information fundamentally, and in that regulation also details in Article 61 that in case a document is requested under access to document, and the information within this document qualifies as information relating to emissions into the environment, there is a presumption of accessibility of these documents that overrules the protection granted by the commercial interest. So, somehow, in some ways, an exception to the exception. So, you need to assess a document. You need to assess its accessibility, and then if document qualifies as emissions into the environment, there is a presumption that overrules the protection of those parts that could qualify for commercial interest protection.
And why? I put this as an example, because as you can imagine, there is a lot of interpretation that is required to these concepts. Fortunately, the European courts are also there to support because there is quite some jurisprudence that provides clarity, but this is a domain where the complexity of the legal assessment and the balancing, I will say, is greater and it’s not worthy.
12:38
Ed
Yeah. Emissions into the environment could cover many areas. It could be chemical substances, it could cover pesticides and can cover pesticides, for example, correct?
12:52
Luisa
Certain information link to pesticides, yes. The court, for instance, ruled out that eco-toxicological study were to be considered. Of course, you need to consider the circumstances of the case, but there are interpretations according to which studies, eco-toxicological studies were considered information relating to emissions and therefore presumptively accessible via access to documents.
13:16
Ed
I mentioned at the beginning transparency and independence of scientists. How does a food safety body like EFSA manage the independence of its scientists? How does it go about that?
13:32
Luisa
You like the values of EFSA, right? Independence is really a core value of EFSA. I think that in our founding regulation is mentioned more than 20 times, as independent risk assessment. And also, in this field we support EFSA in its commitment to ensure that the EFSA is operations, those individuals involved in EFSA operations, primarily the scientific experts, they work impartially.
So, it’s a value that is implemented, it’s detailed in EFSA policy on independence. Just to be noted that EFSA policy on independence was recently updated by the Management Board. So, it’s a Management Board document of EFSA, has been updated in 2024 following an ex-post evaluation which concluded on the positive efficacy of the existing policy but suggested some amendments, not critical. And we did that. So, the Management Board adopted a new policy, updated policy that is then cascaded down in a set of rules. Primarily on the Executive Director decision on what we call competing interests management that sets really the playground, the rules. How do we assess interests by means of declarations of interest? We have nine interest categories.
And then the decision of the Executive Director also details those that are the screening criteria. So again, transparency and independence are connected because all these documents are online, publicly available. So, you can repeat the exercise. You can repeat the assessment.
Also, here, to give you some numbers, last year we processed more than 4500 declarations of interest involvements, more than 3000 of scientists, but we ensure independence for all those involved in the operations, contractors or staff. So, it’s quite a resource intensive job.
15:35
Ed
Yeah. There is a lot that goes on behind it, not just a simple case of implementing it. There has to be a lot that goes into doing this.
15:42
Luisa
Absolutely, but it’s at the core of EFSA’s activities. Independence is really one of the core values to be implemented.
15:50
Ed
Imagine I’m a top expert, the top expert in a particular field that’s very relevant to something that EFSA is doing. But I’ve had contractual work with a relevant company in that area. Yes or no? Could I work for EFSA with that connection?
16:08
Luisa
We used to say that we adopt a total ban. So, there is really a red light when we have employment with food and feed industry, current employment or employment that took place in the previous two years before enrolling in EFSA’s activities. So, my answer is no. If you are employed in food and feed industry, if you were employed in the last two years, if you were employed in the last five years, you cannot be enrolled in EFSA’s activities, or between 5 and 2 years, you cannot be chair or rapporteur in any of our activities. The same apply to financial investments. If you have current financial investments in food and feed industry, you cannot take part of EFSA’s activities.
16:53
Ed
I don’t have either of those things. So, if I want to apply, I guess I’m fine. Another area that I’d like to touch upon, it’s complex, is artificial intelligence, and how that may challenge in some ways, the work that we’re currently doing, artificial intelligence is changing rapidly, but it touches, I think, on lots of the elements of law that you’ve mentioned already. So, is this something that EFSA is already thinking about and what are the areas of law that come into question, come into play when we talk about artificial intelligence?
17:35
Luisa
Thank you. This is a very relevant question. Yes, EFSA is doing already something because of course it’s a big opportunity. Generative AI is an opportunity but is not without challenges. Also here there’s a balancing: balancing between innovation and safeguarding of rights, and security and ethical standards. I think EFSA started quite some time ago already reflecting, by means of a task force, and recently has arrived to an overarching governance structure where also the legal function takes a role, wide legal function. Again, because of course, we have legal acts as well.
We have the AI act, that is where European Union is well advanced, I would say. And you need to adhere to the AI act, but it’s not only that. When you think about using AI, you need to think about unethical use of AI, compliance with the ethical standards, but also compliance with legal frameworks that were in place before the AI, primarily the protection of personal data, the protection of confidentiality information, the protection of IP rights, copyrights. So, all these is ensured by providing the legal unit a function in the AI governance of EFSA. So, we are part of this AI governance. Again, not in isolation. We work also with the other admin unions and with the scientists, those devoted to new technologies and methodologies. So, there is a task force, there is a governance that includes many players, among which the lawyers.
Why? Because we need to ensure compliance also in this domain.
19:20
Ed
And this will be something I imagine you’ll be working on in the years to come.
19:23
Luisa
I think it will be the topic to work in the next year, yes.
19:27
Ed
Okay. Can we bring this all back to the meal that I’m going to have later? And I’ll be thinking about the law, I’ll be thinking about things that you’ve said, how does your daily work on these issues? How does it affect people outside sitting down to their meal? What’s the connection there to what’s going to be on their plate?
19:50
Luisa
I hoped I came across with that. I touched upon certain elements, but indeed the legal work is essential to support EFSA’s mission as a scientific body.
And as I said, behind the science, there are laws and regulatory frameworks, etc., and we support in interpreting them, and we also take administrative decisions for them, especially in the transparency independence. So for instance, if you are cooking your meal, if you are cooking something, and if you think of the safety of that something in all information relating to the safety is publicly available or can be accessible or at the same time, if you think that the safety assessment has been provided by experts that underwent scrutiny on their impartiality according to stringent rules, I think you can add, legal flavour to your meal and feel better reassured of it.
20:50
Ed
I’ll be thinking about that when I eat something later. I think that’s a good note to end it on. Thank you very much, Luisa, for joining us.
20:56
Luisa
Thanks to you.
20:58
Ed
Thank you very much to all our listeners and viewers of Science on the Menu. Please interact with our podcast. You can find us on our different social media. That’s it for now, so, join us again soon on another episode of Science on the Menu. Thank you and goodbye!
O artigo foi publicado originalmente em EFSA.