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.

Table of Contents

• Understanding the Transparency Regulation
• The Purpose and Background of the Regulation
• The Requirement for Pre-Application Notification
• Exceptions and Clarifications
• The Importance of Proactive Notification
• Potential Consequences of Delayed Notification
• The Notification Process: A Simple and Straightforward Approach
• Key Takeaways
• FAQ
  
  

Understanding the Transparency Regulation

The Transparency Regulation was introduced to bring clarity and integrity to the risk assessment process in the food industry.

What is the Transparency Regulation?

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.

Objectives of the Regulation

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.

Key Features

• Increased transparency
• Enhanced reliability
• Objective scientific studies
• Independent assessments
  
  

The Purpose and Background of the Regulation

The Transparency Regulation was developed as a response to past experiences and public demand for more openness in the risk assessment process.

Origin of the Regulation

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.

The Glyphosate Controversy

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.

Goals of the Regulation

• Address past shortcomings
• Improve public trust
• Ensure open processes
  
  

The Requirement for Pre-Application Notification

One of the essential obligations under the Transparency Regulation is the requirement for pre-application notification.

What is 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.

Steps to Obtain a Pre-Application ID

Obtaining a pre-application ID is a straightforward process. It links together all the research pieces that might form part of a future submission.

Types of Research to Notify

• Lab conditions research
• In vitro studies
• Animal studies
• Product stability analysis
• Human clinical trials
  
  

Easy Way to Remember

A simple way to remember what is notifiable is to consider whether the research results in a certificate of analysis or a study report.

Exceptions and Clarifications

While the Transparency Regulation mandates pre-application notification for most research, there are notable exceptions.

Routine Batch Analysis

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.

Good Practice for All Applicants

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.

Potential Future Use

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.

The Importance of Proactive Notification

Proactive notification plays a crucial role in the EFSA application process.

Ensuring Comprehensive Records

Notifying EFSA about planned research ensures that all relevant studies are recorded. This can be valuable for future applications.

Facilitating Future Applications

Having a pre-application ID and pre-notified studies can streamline future submissions. It provides a clear record of all research conducted.

Building a Knowledge Base

Proactive notification helps build a comprehensive knowledge base for EFSA. This can enhance the overall quality and reliability of risk assessments.

Potential Consequences of Delayed Notification

Failure to pre-notify EFSA about planned research can have significant consequences.

Time Penalties

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.

Impact on Application Timelines

Delayed notification can extend the overall timeline for your application. This can delay the approval and market entry of your product.

Increased Scrutiny

Studies not pre-notified may undergo increased scrutiny. This can complicate the review process and potentially impact the outcome of your application.

The Notification Process: A Simple and Straightforward Approach

Notifying EFSA about planned research or testing is straightforward and essential for future applications.

Steps to Notify EFSA

Notifying a study to EFSA involves a few simple steps.

Registering Your Company

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.

Registering Your Study

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.

Co-Notifying Third-Party Contractors

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.

Creating a Profile for Third Parties

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.

Guidance and Support

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.

Key Takeaways

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.

FAQ

Here are some frequently asked questions about the EFSA notification process.

What information is required for pre-notification?

The information needed for pre-notification is high-level. It includes details about the study design, objectives, and population, similar to clinicaltrials.gov registration.

Is the information provided in pre-notification publicly available?

Yes, the information provided during pre-notification is publicly available. However, it is high-level information that does not disclose sensitive details.

Does pre-notification commit me to making a future claim?

No, pre-notification does not commit you to making a future claim. It simply ensures that EFSA is aware of the planned research.

How do I register my company on the EFSA Connect portal?

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.

What if my study involves third-party contractors?

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.

Are there resources to help with the notification process?

Yes, EFSA provides several resources, including webinars and detailed PDF guidance documents. These resources offer comprehensive instructions for the entire notification process.

What happens if I don't pre-notify my study?

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.

Can I pre-notify a study even if I don't have immediate plans for a claim?

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.

What types of research need to be notified?

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.