Novel Food Applications for Synthetic Biology-Derived Products Under the New EU Regulations

On September 30, 2024, the European Food Safety Authority (EFSA) issued new regulations regarding novel foods, including:

• Administrative guidance for novel food applications – Guidelines on the procedural requirements for submitting applications.
• Scientific guidance for novel food applications – Guidelines on safety data requirements for submitted substances.

Both documents have already taken effect on February 1, 2025.

In recent years, there has been a surge in applications for synthetic biology-derived Novel Foods, such as HMOs like 2'-FL and LNnT. As of December 25, 2024, a total of 68 novel foods have been approved since 2020, including 16 synthetic biology-derived products, accounting for 23.5% (see Table 1).

Table 1. Approved synthetic biology-derived novel foods from 2020 to 2024

Given this trend, the European Commission has instructed EFSA to update the novel food application guidelines, reflecting industry needs and EFSA's recent experience in assessing new technologies and processes. The updated guidelines clarify and refine the requirements for synthetic biology-derived products compared to the previous 2021 version. In response, CIRS has summarized key compliance aspects of the new guidelines to help companies navigate the updated application process.

1. Scope: Which synthetic biology-derived products qualify for novel food applications?

According to the EU’s risk assessment guidelines for genetically modified microorganisms (GMM) and their products, the EU classifies GMM and their products into four categories.

Table 2. Risk levels of GMMs and their products

The new guidelines specify that Level 1 and 2 fall under the novel food regulations. This means that even if synthetic biology techniques are used, products can be submitted for novel food approval if they contain no live microorganisms or residual DNA in the final product. Analysis suggests that the EU’s classification system for these products aligns closely with China’s classification of GMMs.

2. Data requirements: What microbial information must be provided?

The new guidelines categorize microorganisms used in Novel Food applications into three types:

• active agents – Novel Foods containing viable, non-GMM microorganisms.
• biomass – Novel Foods containing inactivated, non-GMM microorganisms.
• production strains – GMM or non-GMM microorganisms used in the production of Novel Foods.

For synthetic biology-derived products, microorganisms used in the process are classified as production strains. Key requirements for this category are listed in Table 3:

Table 3. Key requirements for production strains

1. Strains must be deposited in internationally recognized culture collections that comply with the Budapest Treaty. Recognized institutions in China include:

CCTCC: China Center for Type Culture Collection

CGMCC: China General Microbiological Culture Collection Center

GDMCC: Guangdong Microbial Culture Collection Center

2. Reference Document: EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain（EFSA, 2021）

3. Qualified presumption of safety (QPS):

Established by the EU in 2007, QPS is a system for pre-market risk assessment of microorganisms used in food and feed. The evaluation covers taxonomy, scientific knowledge, pathogenicity, and intended use. Microorganisms granted QPS status are included in an official list, which is periodically updated. QPS evaluations are conducted by the EU authorities and cannot be initiated by applicants.

The updated EFSA guidelines provide clearer regulatory requirements for synthetic biology-derived Novel Foods while imposing stricter data submission standards. Given the growing interest in Novel Food applications, precise regulatory interpretation and efficient data preparation are crucial for companies to overcome international compliance barriers and accelerate market entry.

About CIRS Group

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notification, EU novel food application, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.