The global food industry is increasingly driven by innovation in new food ingredients, which offer novel nutritional, functional, or sensory benefits. However, bringing such substances to market requires rigorous approval processes in major markets like China, the European Union, and the United States—each with distinct regulatory frameworks.
A critical question could arise amid this landscape: Do these regions grant protection periods to applicants after their novel food secure approval?
This inquiry touches on the core dynamics of innovation incentives, market competition, and the balance between recouping R&D investments and fostering industry progress.
Under China's Food Safety Law and the Administrative Measures for the Safety Review of New Food Ingredients, there is currently no explicit mechanism to protect the interests of the original applicant (e.g., data exclusivity or exclusive marketing rights). Once approved, the National Health Commission publishes a notice disclosing comprehensive details of the substance, including production process, quality specifications, and conditions of use. Any company whose ingredient meets the published specifications is legally permitted to market the same product, irrespective of which entity filed the original application.
In response, applicants often rely on proprietary processes or higher process&specifications to safeguard their commercial interests. This is especially relevant in the field of synthetic biology. Following the release of China's Application Materials Requirements for Safety Evaluation of Genetically Modified Microorganisms for Food Processing (Trial) in September 2024, new food ingredient submissions have surged. These approvals often specify the microbial strain and require a separate safety assessment—effectively creating market entry barriers for competitors.
Under Regulation (EU) 2015/2283 on novel foods, the EU grants a 5-year data protection period to eligible applicants. During this time, proprietary scientific data submitted in support of the application cannot be used for subsequent approvals without the applicant's consent.
To qualify for data protection, the following conditions must be met:
The data must be designated as proprietary at the time of submission;
The applicant must own the exclusive rights to the data;
The novel food could not be assessed or authorized without this data.
It is worth noting that this protection does not apply to traditional foods from third countries. Once the five-year period expires, any food business operator may market the substance, provided their product complies with the specifications outlined in the Union List.
Under the FSANZ Act, Food Standards Australia New Zealand (FSANZ) may grant exclusive permissions for novel foods or nutritional ingredients tied to a specific brand. During the exclusive period, only that brand may market the ingredient.
Exclusive permissions are issued in line with FSANZ's evaluation criteria under Sections 18 and 29 of the Act, considering:
Whether the measure's cost outweighs its societal, governmental, or industry benefits;
The availability of more cost-effective alternatives;
Other relevant factors, such as:
Scientific and economic evidence supporting risk-based analysis;
The importance of industry efficiency and global competitiveness.
The exclusive permission typically lasts 15 months from the date of gazettal. FSANZ is not required to specify the product's brand or category in all cases, though it may impose limits on usage. After the exclusivity period ends, the permission automatically converts into a general approval with no brand restrictions.
In practice, FSANZ considers exclusivity only when expressly requested—usually as part of a paid application—due to its commercial value to the applicant.
In addition, several other countries have introduced their own regulatory requirements to balance innovation with public accessibility. For example:
Thailand issues non-public licenses valid only for the applicant;
Brazil offers partial protection depending on the specifications used;
The United States distinguishes between regulatory pathways (e.g., FDA food additive petition, FDA GRAS notice, self-affirmed GRAS, NDIN for dietary ingredients), with varying levels of protection—only the food additive petition path is universally accessible.
The cost of developing and registering novel food ingredients is high. Regulatory protections play a crucial role in incentivizing companies to invest in innovation. Businesses should consider local policies when entering new markets and apply for appropriate protection rights to strike a balance between R&D costs and commercial returns—ultimately driving sustained innovation in the food ingredient sector.
