In 2021, the European animal nutrition and health market are facing two important regulatory changes that impact how feed additives are registered. The first challenge is the application of the Transparency Regulation and subsequent changes to the European Food Safety Authority (EFSA) risk assessment of such products. The second one is the withdrawal of the UK from the European Union (EU). The main consequence of these changes is that applicants now need more time and investment to achieve feed additive approval in two different and increasingly divergent geographical and regulatory markets. Eliana Henriquez at Pen & Tec elucidates about the feed additives registrations.
‘Feed Additive Registrations – the Post-Transparency and BREXIT Era’
In the EU, EFSA is responsible for the risk assessment of all food chain REgulated PROducts (REPRO) and all GMOs, including feed additives. Since 27 March 2021, EFSA applies the provisions of the recent Transparency Regulation (1, Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019). Two of the main objectives of this regulation are:
- To increase the transparency of the EU risk assessment in the food chain.
- To strengthen the reliability, objectivity and independence of the studies used by EFSA for their assessment.
To achieve these objectives, EFSA and EU authorities have developed a series of new requirements and procedures with which applicants must comply when developing feed additive dossiers, particularly those related to pre-submission activities.
Notification of studies using the EFSA Connect Portal (Transparency Regulation, Article 32B)
All studies performed after 27 March 2021 for supporting feed additive applications must be notified using the EFSA Connect Portal (2) before the study start date. For each study, applicants must notify the following information:
- Title of the study.
- Scope (intended study area, study type, study international standard certification, study objective, test item).
- Name of the laboratory/contract research organisation (CRO) where the study will be performed.
- Study planned start and end date.
Additionally, laboratories/CROs located in the EU, Iceland, Liechtenstein, Norway and Northern Ireland must co-notify studies and, therefore, should also be registered on the EFSA Connect Portal.
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