Influenced by globalization and strategic development, an increasing number of companies applying for novel food are expanding their target market, with the EU being one of the most popular destinations. Whether it is the application for new food ingredients/additives/enzymes or for new feed ingredients/additives, companies are required to conduct a series of tests. The EU, under its transparency regulations, requires companies to submit pre-notifications of tests before conducting them—this is a unique EU requirement. Failure to notify in advance without a valid justification may result in delays or penalties in the application process. In this article, CIRS Group provides an introduction for companies on EU pre-notification requirements for applications.
Regulatory Background
- Regulation (EU) 2019/1381, abbreviated as Transparency Regulation (TR);
- Regulation (EC) No 178/2002, abbreviated as General Food Law Regulation (GFL).
Article 32b of the revised GFL stipulates that starting from March 27,2021, companies are required to immediately submit a pre-notification to the EFSA of any tests they are about to commission or conduct. The purpose is to ensure that EFSA is fully informed in advance of all studies carried out by companies in support of substance applications under EU regulations.
Which Tests Require Pre-notification?
According to the Q&A guide on GFL Article 32b and EFSA practice arrangements, taking the application for novel food and new food additives produced by genetically modified microorganisms as an example, CIRS Group has sorted out whether the relevant major tests need to be notified in advance for reference by companies.
|
Category |
Test |
Whether pre-notice is required |
|
Final product |
Component analysis (including impurities and physicochemical properties) |
No |
|
Test for absence of viable bacteria |
Yes |
|
|
Test for absence of DNA residue |
Yes |
|
|
Stability test |
Yes |
|
|
Toxicology test |
Yes |
|
|
Production strain |
Whole genome sequencing (WGS) |
No |
|
Bioinformatics analysis |
Yes |
|
|
Drug resistance test |
Yes |
|
|
Pathogenicity test |
Yes |
|
|
Genetic stability |
Yes |
Note: The specific tests may vary depending on the substance in question and should be analyzed on a case-by-case basis.
Submission Process of Pre-Notification
- Register an account on the EFSA Connect system.
- Submit substance information to obtain a pre-application ID.
- Add the tests under the pre-application ID.
- Complete submission details (including test name, type, purpose, start/end dates, detection method, laboratory or testing institution).
What if the Pre-notification was not Carried Out in Advance?
If an experiment is not pre-notified or delayed notification, valid justification must be provided. Failure to do so will result in a non-acceptable application and a six-month evaluation delay penalty. Even if the final results of a pre-notified test are unsatisfactory, submission of the test report is mandatory. Failure to submit will require a reasonable explanation, otherwise, EFSA may raise safety concerns about the substance.
In summary, given EFSA’s strict compliance requirements for transparency regulations, CIRS strongly advises EU-compliant enterprises to carefully address pre-notification obligations. Companies should plan in advance and complete pre-notification procedures before conducting tests.
About Us
The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 domestic and international food and feed companies in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions including:
- China - “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
- China - New Feed and New Feed Additive Application
- US - FDA GRAS Notice
- US - Animal Food GRAS Conclusions
- EU - Novel Food Application
- EU - Food Enzyme (Food Enzyme Preparation) Application
- EU - Food Additive Application
- EU - Feed Additive Application
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
