Business confidentiality: The ‘hot potato’ of new EU transparency rules on food

Under the EU Commission’s proposed rules, the European Food Safety Authority (EFSA) remains entitled with this task, which puts it often in a difficult position. [Sarantis Michalopoulos]

This article is part of our special report A difficult balance: Science, politics and policy-making on food.

EU stakeholders are playing ping-pong with the body that will be responsible for deciding whether or not to break business confidentiality and make industry studies public, in line with the terms of the new transparency rules on food safety. EURACTIV.com reports from Parma.

Under the European Commission’s proposed rules, the European Food Safety Authority (EFSA) remains responsible for this task, which often puts it in a difficult position.

Diplomats explain that there are a number of options on the table, including the establishment of new bodies.

In an effort to provide more transparency in the decisions related to approvals in the agri-food chain, following the controversy surrounding the glyphosate debate, the Commission presented in April new proposals that grant EU citizens greater access to information submitted to EFSA.

The denial of access to scientific studies used for the authorisation of products in the name of business confidentiality has triggered strong reactions from health advocates and policymakers, who accuse the chemical industry of lacking transparency.

According to the proposed rules, all studies and supporting information that is submitted to EFSA for risk assessments are made public “proactively and automatically”. However, confidential information will still be protected “in justified circumstances, to be verified by the Authority”.

Who is going to interpret the business confidentiality is the “hot potato”, which no one wants to hold.

For different reasons, both environmental NGOs and the industry are pushing for amendments to the Commission’s new transparency rules on food.

NGOs express their concerns, saying that the industry could still take advantage of the legislation loopholes and avoiding publishing all the studies.

“While industry-funded studies play a very important role in EFSA’s evaluations of pesticides and other food-related products, only summaries of these studies are so far published, no full study reports,” the NGOs noted.

Although they believe that in general, the proposed rules are a move in the right direction, the organisers of the “Stop Glyphosate” European Citizens’ Initiative are pushing for specific amendments, which they say should lead to more transparency in decision-making.

They insist that the final text should not leave room for “contentious interpretation”, protecting EFSA from excessive confidentiality claims and costly litigations by industry.

Franziska Achterberg, Greenpeace EU food policy adviser, told EURACTIV that the public need to have the opportunity to see whether EFSA’s conclusions are in line with the evidence presented.

“So far, the studies submitted by the industry have been secret and just some summaries have been made public,” she explained.

Referring to industry’s responsibility, she noted that it should agree that it’s in the public interest to release these studies.

“We have heard arguments such as that competitors could use the studies for product approvals outside Europe, in another regulatory context. These are some issues to be sorted out among companies. It cannot be a reason to keep studies secret,” she emphasised.

PAN Europe, a network of European NGOs promoting sustainable alternatives to pesticides, insists that the reform of the General Food Law must be much clearer on what EFSA is allowed to release and what is considered as commercially sensitive and therefore confidential.

“For the moment, the proposal is not clear enough; it’s too vague regarding what the industry could claim as commercially sensitive,” PAN Europe’s Martin Dermine said.

“There must be an exhaustive list of what can be claimed, such as the production process but not, for instance, the list of ingredients of pesticides that are being sprayed to the environment. In our view, the lack of clarity of the past impeded or made it difficult for EFSA to disclose information,” he told EURACTIV.

Asked to comment on the legal cases pushed by NGOs against EFSA, he replied that if there was more clarity, if NGOs obtained the data of toxicological studies, there would be no need to have a court case.

“We don’t care how a pesticide is produced but we want to know if people are exposed and if it’s toxic. This is information that belongs to the general public, not to the industry.”

“Open EFSA”

An EFSA spokesperson hailed the Commission’s proposal for more transparency of the EU system, saying it would increase the scrutiny of the operations, and this resonates with EFSA’s strategic ambition for an “Open EFSA”.

“Political discussions are ongoing and whatever the outcome of the negotiations will be, EFSA will continue to work within the legal framework that the legislators will decide on,” the EFSA official noted.

So far there have been five cases where EFSA has defended itself concerning confidentiality decisions.

Asked about the cost of these cases, the EFSA spokesperson replied that on average figures for support services could be roughly around €30,000.

“This figure does not include the internal costs (time spent by EFSA staff on each court case).”

Another body?

A diplomat close to the issue told EURACTIV that the Austrian EU Presidency made another proposal regarding the issue last week.

According to the diplomat, Vienna suggested this role be assigned to the European Commission, but the EU executive allegedly denied such a role.

Then the EU Council proposed the establishment of a First Instance Committee within EFSA and a Second Instance Committee in the European Court of Justice (ECJ).

The committees will be responsible for the confidentiality claims but the level of their independence or its relation with EFSA is not yet clear.

The Austrian Presidency is now waiting for the member states’ comments on its proposal, which could then be possibly discussed at the next meeting.

Industry: We have nothing to hide

The industry also sees the Commission’s proposals in a positive light but insists on amendments to ensure the protection of confidential business information.

In March, the EU pesticide industry association (ECPA) announced a global commitment to make all safety-related data from studies publicly available.

“We wanted to make a clear statement demonstrating that we have nothing to hide,” Graeme Taylor, a spokesperson for ECPA, told EURACTIV.

Taylor said amendments to certain provisions in the proposal were needed to strike the right balance between ensuring transparency in the risk assessment process and protecting what is “truly legitimate” confidential business information.

“Not because we have an interest in keeping anything from citizens or decision-makers, but from those who might choose to misuse the information, for example by using the names of scientists or addresses of laboratories where testing is carried out to be able to target people,” he emphasised.

He explained that the pesticide industry invests more than €5 billion each year in research and development, and it now takes on average 11 years and €250 million to successfully bring a new substance to market.

“Being able to safeguard confidential business information is essential to guaranteeing continued innovation and investment by our sector in Europe,” he concluded.

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