Europe’s new rules for food safety approval: Building trust in science?
The European Parliament ratified the proposals, which have already been agreed with EU ministers, today (17 April). MEPs passed the regulation, which intends to make food safety assessments more “reliable, transparent and objective”, by 603 votes in favour with 17 against
Trust and transparency
The updated regulations aim to build trust in the food safety approvals process. According to the European Commission, European citizens report a lack of trust over the transparency of European Food Safety Authority’s risk analysis, particularly for the authorisation dossiers.
EFSA’s food safety assessments are currently primarily based on industry studies – data and information generated and funded by the applicant – and this has led to a degree of suspicion. According to the EC’s assessment, such misgivings are compounded by the strict confidentiality rules EFSA operates under regarding these studies, which are currently not publicly disclosed.
In order to address this, in April the EC officially proposed a targeted revision of the General Food Law (GFL) regulation. The EC hopes to provide citizens with greater confidence in EFSA’s applications process.
Unfavourable studies will no longer be withheld
The most significant change under the new rules will see the creation of a common European Database of commissioned studies. The intent is to deter companies applying for authorisation of food stuffs from withholding unfavourable studies from regulators.
This will allow the EFSA to make submitted studies public for third-party scrutiny. This information may then be used to identify whether other relevant scientific data or studies exist, to ensure accuracy, regulators said.
To ensure transparency, applicants for food safety approval will be required to disclose all information relevant for assessing safety. However, some information, such as the manufacturing or production process, may be kept confidential. This aims to help protect intellectual capital and innovation.
Finally, the new law also supports the implementation of a new pre-submission advisory procedure that enables EFSA to advise applicants on how to submit their application for authorisation correctly, making the process more reliable.
The legislation’s Spanish rapporteur, Pilar Ayuso (EPP), said the new rules would build consumer trust in a decision-making process built on scientific evidence.
"This agreement enables us to have a decision-making process based on scientific evidence, to guarantee a high level of security and public health in Europe, whilst improving public trust and confidence in the decision-making process by making it more transparent,” Ayuso suggested.
The Council of Ministers now needs to formally approve the text before it can enter into force.
Full disclosure or political maneuvering?
Environmental campaign groups and consumer organisations welcomed the move – with some caveats.
Greenpeace EU food policy director Franziska Achterberg said it was a positive that scientific studies commissioned by industry interests would now be open to third party inspection. However, Achterberg noted, the industry will still “test the safety of its own products”.
“The chemical industry will still test the safety of their own products, but at least now the studies will be published so that independent scientists can scrutinise their contents and the advice EFSA gives to lawmakers. EFSA has in the past privileged corporate interests over the public’s right to know, so we will be watching closely to see that the new rules are properly applied.”
Meanwhile, European consumer organisation BEUC said it was “high time” the “secrecy” around EFSA’s decision making process came to an end.
BEUC Director General, Monique Goyens, said that the database of studies will block the industry from hiding research that delivers unfavourable results.
“We will have to remain vigilant, however, on how the new transparency rules work in practice. Independent scientists should be able to access, use and quote safety data produced by the food industry without having to seek permission,” Goyens commented.
However, the consumer advocate stressed that the regulation does little to open up the political interests behind decision-making, arguing that the requirements could “easily have gone further”.
“EU policy makers should also have lifted the lid on the political choices made to address the safety risks identified by EFSA. To regain trust, consumers must know why an option is chosen over another to address a given risk. For example, consumers deserve to know why the EU chooses to set legal limits for a risky substance rather than a full ban.
“What we need is for Member States’ votes to become public when it comes to decisions to ensure that food on consumers’ plate is safe.”
Real versus perceived risks: Transparency to tackle 'scaremongering'
From the opposite side of the debate, EuropaBio, which represents the European biotech industry, also welcomed the move to increase transparency.
In contrast to environmentalists, the association hopes that by addressing the trust-gap assessed products, including GMOs, can regain consumer confidence in the region.
“Science and fact must take precedence over fear and misinformation,” said Joanna Dupont-Inglis, Secretary General of EuropaBio. “We hope that the new rules will help to build much needed trust in our food chain, including in assessed products like GMOs.
“The focus should now finally be on delivering a sustainable and efficient risk assessment process and on informing the wider public about real versus perceived health risks, which means tackling scaremongering and misperceptions. For the system to be trusted, it is crucial that science and facts are communicated properly. Consumers should be able to rest assured that their food is safe.”
Like the BEUC, Dupont-Inglis expressed concerns that political motivations are helping to undermine trust in approval processes. However, she insisted, this has been detrimental to the uptake of GMOs that are deemed to be safe.
“The refusal of certain Member States and decision makers to support approvals of thoroughly risk assessed GM plants which are proven to be as safe as conventional plants enormously erodes trust in science and risk assessment. Likewise, any legislative requirements which are based on fear campaigns rather than on sound science further damage and undermine trust.”
Protecting research and innovation?
The transparency drive must also ensure that legitimate confidential business information remains protected, Dupont-Inglis continued. The establishment of pre-submission meetings should enable a clearer and more streamlined risk assessment process, the biotech proponent added.
FoodDrinkEurope, the lobby group representing the interests of European food processors, also expressed some reservations that the new rules could dampen innovation in the bloc.
"FoodDrinkEurope has expressed its concern on the potential impact the proposal may have on the competitiveness of the EU food and drink industry and welcomes initiatives that have been introduced to the regulation to protect innovation within the EU risk assessment model.
"FoodDrinkEurope members have committed to increase the value added of the sector by 2.5-3.5% annually and the industry is on track to achieve this; but we need a policy landscape that is open to growth and to research and innovation."