The EU's Transparency Regulation has introduced new requirements for notifying EFSA about planned research and testing. In this comprehensive blog post, we'll walk you through the entire process, from obtaining a pre-application ID to co-notifying third-party contractors. Discover the benefits of proactive notification and how to future-proof your applications.
The Transparency Regulation was introduced to bring clarity and integrity to the risk assessment process in the food industry.
The Transparency Regulation, also referred to as the Transparency Act, is an EU regulation enacted in March 2021. It aims to enhance the transparency of risk assessments in the food chain.
The regulation seeks to improve the reliability, objectivity, and independence of scientific studies. These studies are crucial for supporting risk assessments in the food industry.
The Transparency Regulation was developed as a response to past experiences and public demand for more openness in the risk assessment process.
The regulation was partly a reaction to past events, such as the controversy surrounding the glyphosate weed killer. This incident highlighted the need for more transparency in the process.
In 2017-2018, a citizens' initiative petitioned to ban glyphosate. This event revealed a lack of transparency in the risk assessment process, prompting the creation of the Transparency Regulation.
One of the essential obligations under the Transparency Regulation is the requirement for pre-application notification.
Applicants seeking health claims or novel food submissions must obtain a pre-application identification number. They must notify EFSA of planned research and testing before it occurs.
Obtaining a pre-application ID is a straightforward process. It links together all the research pieces that might form part of a future submission.
A simple way to remember what is notifiable is to consider whether the research results in a certificate of analysis or a study report.
While the Transparency Regulation mandates pre-application notification for most research, there are notable exceptions.
EFSA clarified that routine batch analysis of production batches is not required to be notified in advance. This clarification came into effect around August last year.
Even if you don't have immediate plans for health claims or novel food submissions, obtaining a pre-application ID is still recommended. This practice doesn't commit you to future actions but can be beneficial.
Any study that could be included in a future application should be pre-notified. This ensures EFSA has prior knowledge of all relevant research, supporting any future submissions.
Proactive notification plays a crucial role in the EFSA application process.
Notifying EFSA about planned research ensures that all relevant studies are recorded. This can be valuable for future applications.
Having a pre-application ID and pre-notified studies can streamline future submissions. It provides a clear record of all research conducted.
Proactive notification helps build a comprehensive knowledge base for EFSA. This can enhance the overall quality and reliability of risk assessments.
Failure to pre-notify EFSA about planned research can have significant consequences.
If you decide to make a health claim or novel food submission later, delayed notification can result in time penalties. EFSA may need extra time to review the studies retrospectively.
Delayed notification can extend the overall timeline for your application. This can delay the approval and market entry of your product.
Studies not pre-notified may undergo increased scrutiny. This can complicate the review process and potentially impact the outcome of your application.
Notifying EFSA about planned research or testing is straightforward and essential for future applications.
Notifying a study to EFSA involves a few simple steps.
1. Register your company on the EFSA Connect portal.The first step is to register your company as an entity within the EFSA Connect portal. This step is essential to proceed with any notifications.
Once your company is registered, you need to register the study before it starts. This is crucial as it ensures that EFSA is aware of the planned research.
After registering the study, you must trigger a request to any third-party laboratory or contractor involved. They need to co-notify the study, which is a simple process done via email.
Third parties must create a profile through the EFSA Connect portal to co-notify. Once their profile is set up, they can easily co-notify the study.
EFSA provides detailed guidance through webinars and PDF documents. These resources offer step-by-step instructions, from setting up an account to completing the pre-notification.
1. Understanding EFSA Notifications: Understanding the EFSA (European Food Safety Authority) notification process is critical for ensuring compliance in GMO-related research.
2. Compliance Steps: Follow these steps: submit your study plan, provide detailed details, and wait for approval before beginning your project.
3. Preparation Tip: To avoid delays, ensure that all of your data is precise and comprehensive.
4. Importance of Documentation: Keep detailed records of all communications and submissions to the EFSA.
5. Expert Guidance: To successfully handle difficult regulatory obligations, consider engaging with specialists.
Following these measures assures compliance and a seamless research process.
Here are some frequently asked questions about the EFSA notification process.
The information needed for pre-notification is high-level. It includes details about the study design, objectives, and population, similar to clinicaltrials.gov registration.
Yes, the information provided during pre-notification is publicly available. However, it is high-level information that does not disclose sensitive details.
No, pre-notification does not commit you to making a future claim. It simply ensures that EFSA is aware of the planned research.
To register your company, visit the EFSA Connect portal and follow the registration steps. Detailed guidance is available in EFSA's PDF document and webinars.
If your study involves third-party contractors, you need to trigger a request for them to co-notify. They must create a profile on the EFSA Connect portal to complete this step.
Yes, EFSA provides several resources, including webinars and detailed PDF guidance documents. These resources offer comprehensive instructions for the entire notification process.
Failing to pre-notify can lead to time penalties and increased scrutiny during the review process. It can also extend the overall timeline for your application.
Yes, pre-notifying a study is recommended even if you don't have immediate plans for a health claim or novel food submission. It ensures that EFSA has prior knowledge of all relevant research.
Research conducted under lab conditions, in vitro studies, animal studies, product stability analysis, and human clinical trials must be notified. Routine batch analysis is an exception.