News
October 20, 2026
Explore how EFSA evaluates feed additives such as Bovaer®, and how independent scientific assessment supports EU authorization and ongoing regulatory oversight.
Before any feed additive can be used in the European Union, it must pass one of the world's most rigorous authorization procedures. The process is designed to ensure that products placed on the market are both safe and effective, with responsibilities shared between independent scientific experts and regulatory authorities.
Bovaer®, the methane-reducing feed additive developed for cattle, underwent this full process before receiving authorization for use in the European Union in April 2022 for use in dairy cows and cows for reproduction. Since then, a growing body of scientific research and practical farm experience has continued to expand the evidence supporting its use.
A defining feature of the EU system is the separation between scientific assessment and regulatory decision-making.
The European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence. Its role is to determine whether a product is safe and effective based on the available data. The regulatory decision is then taken separately by the European Commission together with EU Member States.
This distinction, established under EU feed additive legislation, ensures that scientific conclusions are developed independently from policy decisions.
In simple terms, EFSA answers the scientific question: Is the product safe and does it work? The European Commission and Member States then determine whether the product should be authorized and under what conditions.
Before a feed additive can receive a positive opinion, it must successfully meet multiple requirements.
EFSA's scientific evaluation examines five key areas:
All five categories are considered as part of EFSA’s assessment. Its conclusions are then reflected, as appropriate, in the conditions and requirements specified in the authorization. The authorization process may not proceed if EFSAs conclusions do not support the safety and efficacy of the additive under the proposed conditions of use.
The assessment is based on a comprehensive scientific dossier that includes studies, methodologies, datasets and statistical analyses. EFSA experts independently review the evidence and reach their own conclusions.
While companies are responsible for generating and submitting the studies required for authorization, the scientific assessment itself is conducted independently.
EFSA's FEEDAP Panel (Panel on Additives and Products or Substances used in Animal Feed) reviews the submitted evidence, scrutinizing study design, data quality, analytical methods and statistical approaches. Panel members are subject to strict requirements concerning independence and conflicts of interest.
In accordance with EU transparency requirements, EFSA makes its scientific opinions publicly available, enabling researchers, policymakers, journalists and farmers to review the conclusions and supporting rationale.
Bovaer® followed this process in full.
In 2021, EFSA's FEEDAP Panel issued a positive scientific opinion covering all required assessment areas. Following that opinion, the European Commission adopted Implementing Regulation (EU) 2022/565, authorizing Bovaer® for use in the European Union in April 2022 in dairy cows and cows for reproduction.
Like all EU feed additive authorizations, Bovaer’s authorization is time limited, with a 10-year validity period ending 28 April 2032. It remains subject to ongoing regulatory oversight and may be reassessed at any time during the 10-year authorization period if new scientific evidence emerges.
Scientific assessment does not end when a product is authorized.
One of the strengths of the EU regulatory framework is its ability to re-examine evidence when new questions arise. Following concerns reported by the Danish Authorities, the European Commission requested EFSA to carry out an updated assessment of the safety of Bovaer® considering the additional information available.
As part of this process, EFSA launched a public call for data in spring 2026, inviting researchers, institutions, the authorization holder and other interested stakeholders to submit relevant scientific and farm-level evidence.
The call for data is intended to expand the existing evidence base by incorporating real-world experience alongside newly generated data. EFSA has indicated that the quantity and complexity of submissions require careful review, with its scientific opinion currently expected on 30 November 2026.
Importantly, Bovaer® remains fully authorised throughout this review process.
At the time of its EU authorization in 2022, Bovaer® was already backed by an extensive scientific track record. Since then, this evidence base has continued to expand through additional research and practical farm experience.
Today, the evidence base includes:
Independent institutions, including Wageningen University & Research, Penn State University, Teagasc and researchers from Aarhus University, have contributed to this growing body of scientific evidence on Bovaer®.
As a result, the quantity of scientific evidence available today is considerably greater than that reviewed during the original authorization process.
Bovaer® was authorized through a process that combined independent scientific assessment by EFSA with regulatory review by the European Commission and EU Member States. That authorization remains valid until 28 April 2032.
The scientific evidence supporting the product has continued to grow through additional research, commercial experience, and ongoing regulatory review. EFSA's 2026 call for data illustrates how the European regulatory system responds to emerging questions by gathering additional evidence and subjecting it to scientific assessment.
Such reviews are part of the EU’s regulatory system, ensuring that decisions remain grounded in the latest available evidence.
As EFSA prepares to publish its updated assessment, the combination of peer-reviewed research, practical farm experience and continued scientific scrutiny continues to contribute to confidence in the safety and efficacy of Bovaer®.
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